The BalanceBelt is an innovative tool for people with serious balance problems such as BVL, UVL and PPPD. The belt warns the wearer with vibrations in the event of a loss of balance, which improves stability and reduces the risk of falling. The sale of the BalanceBelt in America requires FDA approval. An experienced U.S. consulting firm, with former FDA employees, is called in to guide this process. Their tasks are: • Investigate if the 510(k) route is possible, the fastest and cheapest way to FDA approval. • Submitting and supervising a Q-submission, with the FDA advising on the best submission route. • Accompanying and submitting the application itself. • Guide negotiations and talks with the FDA. The goal is to obtain an 'Approval to Market', through which the BalanceBelt can be sold in America.